PDF(Pubmed)
Abstract：
BACKGROUND: Providing informed consent for trials requires providing trial participants with comprehensive information about the trial, including information about potential risks and benefits. It is required by the ethical principle of respecting patient autonomy. Our study examines the variation in the way information about potential trial benefits and harms is shared in participant information leaflets (PILs).
METHODS: A total of 214 PILs and informed consent forms from clinical trials units (CTUs) and Clinical Research Facilities (CRFs) in Ireland and the UK were assessed by two authors independently, to check the extent to which they adhered to seven recently developed principles. Discrepancies were resolved by a third.
RESULTS: Usage of the seven principles varied widely between PILs regardless of the intended recipient or trial type. None of the PILs used more than four principles, and some (4%) used none. Twenty-seven per cent of PILs presented information about all known potential harms, whereas 45% presented information on all known potential benefits. Some PILs did not provide any potential harms or potential benefits (8%). There was variation in the information contained in adult and children PILs and across disease areas.
CONCLUSIONS: Significant variation exists in how potential trial benefits and harms are described to potential trial participants in PILs in our sample. Usage of the seven principles of good practice will promote consistency, ensure informed ethical decision-making and invoke trust and transparency. In the long term, a standardised PIL template is needed.
METHODS: A total of 214 PILs and informed consent forms from clinical trials units (CTUs) and Clinical Research Facilities (CRFs) in Ireland and the UK were assessed by two authors independently, to check the extent to which they adhered to seven recently developed principles. Discrepancies were resolved by a third.
RESULTS: Usage of the seven principles varied widely between PILs regardless of the intended recipient or trial type. None of the PILs used more than four principles, and some (4%) used none. Twenty-seven per cent of PILs presented information about all known potential harms, whereas 45% presented information on all known potential benefits. Some PILs did not provide any potential harms or potential benefits (8%). There was variation in the information contained in adult and children PILs and across disease areas.
CONCLUSIONS: Significant variation exists in how potential trial benefits and harms are described to potential trial participants in PILs in our sample. Usage of the seven principles of good practice will promote consistency, ensure informed ethical decision-making and invoke trust and transparency. In the long term, a standardised PIL template is needed.
摘要：
背景：为试验提供知情同意需要向试验参与者提供有关试验的全面信息，包括有关潜在风险和收益的信息。这是尊重患者自主权的道德原则所要求的。我们的研究检查了参与者信息传单（PILs）中有关潜在试验益处和危害的信息共享方式的变化。
方法：来自爱尔兰和英国的临床试验单位（CTU）和临床研究机构（CRF）的总共214份PILs和知情同意书由两名作者独立评估，检查他们遵守最近制定的七个原则的程度。差异由三分之一解决。
结果：七项原则的使用在PIL之间差异很大，而与预期的接受者或试验类型无关。没有一个PIL使用超过四个原则，有些人（4％）没有使用。27%的PILs提供了关于所有已知潜在危害的信息，而45%的人提供了所有已知潜在益处的信息。一些PIL没有提供任何潜在的危害或潜在的益处(8%)。成人和儿童PILs以及不同疾病区域中包含的信息存在差异。
结论：在我们的样本中，潜在的试验获益和危害是如何描述潜在的试验参与者的。使用良好做法的七个原则将促进一致性，确保知情的道德决策，并援引信任和透明度。从长远来看,需要一个标准化的PIL模板。
方法：来自爱尔兰和英国的临床试验单位（CTU）和临床研究机构（CRF）的总共214份PILs和知情同意书由两名作者独立评估，检查他们遵守最近制定的七个原则的程度。差异由三分之一解决。
结果：七项原则的使用在PIL之间差异很大，而与预期的接受者或试验类型无关。没有一个PIL使用超过四个原则，有些人（4％）没有使用。27%的PILs提供了关于所有已知潜在危害的信息，而45%的人提供了所有已知潜在益处的信息。一些PIL没有提供任何潜在的危害或潜在的益处(8%)。成人和儿童PILs以及不同疾病区域中包含的信息存在差异。
结论：在我们的样本中，潜在的试验获益和危害是如何描述潜在的试验参与者的。使用良好做法的七个原则将促进一致性，确保知情的道德决策，并援引信任和透明度。从长远来看,需要一个标准化的PIL模板。
